Forefoot Orthotic Device

ABSTRACT

A forefoot orthotic device has multiple regions configured so that impact, propulsive or standing forces experienced by the forefoot of the user are accelerated, decelerated, shifted, transferred, or lessened, so as to promote pain reduction or otherwise address or treat conditions of the forefoot. In one implementation, the device includes expanded areas adapted to underlie the first and fifth metatarsal heads and cushion or offload forces therefrom. In still other variations, the device includes a plateau and regions adjacent the plateau and sloping downwardly therefrom, so that the time during which painful regions of the forefoot experience force, such as during gait or standing, is lessened in favor of transferring such forces to adjacent regions which potentially are less in need of treatment or protection from such forces.

FIELD

This disclosure relates to orthotic devices and, more particularly, to aforefoot orthotic device for use in connection with a user's foot.

BACKGROUND

Orthotic devices are useful for treating disorders, injuries, diseasesor other harmful or painful foot conditions. Orthotic devices includemetatarsal pads, often made of foam, and which cushion the metatarsalregion of a user's foot which may overlie such pad, such as when suchpad is inserted within footwear.

Orthotic devices for the forefoot of the current art suffer from variousdrawbacks and disadvantages.

Accordingly, there is a need for an improved forefoot orthotic device toaddress foot conditions of a user, including injuries, disorders,diseases and their associated trauma, pain, or other discomforts.

SUMMARY

In one possible implementation, a forefoot orthotic device for use inconnection with the user's foot includes a resiliently compressibleelement sized and shaped to underlie the forefoot. The element is sizedand shaped so that there are two, expanded areas of resilientlycompressible material located toward the distal end of the element atrespective lateral and medial sides. The expanded areas are transverselyspaced from each other by a predetermined amount corresponding to thedistance between the first and fifth metatarsal heads of the user'sfoot.

In further implementations, the forefoot orthotic device has an uppersurface which extends upwardly and inwardly from the circumferentialedge of the forefoot orthotic device, the surface having an upperportion defining a plateau raised relative to a lower plane of referenceassociated with the forefoot orthotic device.

In other variations of the disclosure, the resiliently compressibleelement includes lateral and medial areas which extend upwardly in atransverse direction so as to form an arch. The arch is located tounderlie the metatarsal arch of the user's foot.

In still further versions of forefoot orthotic devices disclosed herein,the upper surface of the orthotic device has medial and lateral areaswhich are more rigid than portions of a proximal area adjacent to suchmedial and lateral areas. In this way, during use, deceleration of footportions overlying the medial and lateral areas is greater thandeceleration of foot portions overlying the adjacent portions of theproximal area, with the effect that force experienced in the metatarsalarea is reduced or slowed in comparison to force experienced proximallythereto.

In still other variations, the medial and lateral areas of the uppersurface are more rigid than portions of a distal area adjacent to suchmedial and lateral areas. As such, acceleration of forefoot portionsoverlying the distal area is greater than acceleration of forefootportions overlying the medial and lateral areas.

In still further variations, devices according to the present disclosuremay have a concavity formed in the lower surface of the resilientlycompressible element, and the resiliently compressible material in suchconfiguration is chosen so that weight or force associated with the userdeflects the concavity toward a lower plane of reference during the gaitcycle of such user, or in response to standing under load associatedwith the user's weight.

The forefoot orthotic device of the present disclosure includes featureswhich take into account biomechanics of the user, both at various phasesof the user's stance or gait, including the impact, swing, andpropulsive phases of the user's gait, as well as points intermediate tosuch phases. The device is useful to address abnormalities or uniquecharacteristics of a person's gait from whatever cause, whether fromfoot conditions or musculoskeletal factors.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure herein will be more readily understood with reference tothe drawings, in which:

FIG. 1 is an isometric view showing a forefoot orthotic device accordingto the present disclosure;

FIG. 2 is a rear-elevational view of the orthotic device of FIG. 1;

FIG. 3 is a top-plan view of the orthotic device of FIGS. 1-2;

FIG. 4 is a front view of the orthotic device of FIGS. 1-3;

FIG. 5 is a side-elevational view of the orthotic device of FIGS. 1-4;

FIG. 6 is a bottom-plan view of the orthotic device of FIGS. 1-5;

FIG. 7 is an exploded, isometric view of another implementationaccording to the present disclosure, in the form of an insole;

FIG. 8 is a top-plan view of the implementation of FIG. 7;

FIG. 9 is a side-sectional view of the implementation of FIGS. 7-8;

FIGS. 10 and 11 are bottom plan and isometric views, respectively, ofanother implementation according to the present disclosure in the formof a sleeve or sock;

FIG. 12 is an isometric view of footwear according to the presentdisclosure;

FIGS. 13 A&B and 14 A&B are orthotic scans showing pressure or force onthe forefoot without and with an orthotic device according to thepresent disclosure.

DETAILED DESCRIPTION

Referring to the drawings, FIGS. 1-6 show a forefoot orthotic device 21,configured in this implementation to be an insert for use in footwear inconnection with a user's foot. Orthotic device 21 comprises an element23 formed of resiliently compressible material. Element 23 of theforefoot orthotic device 21 is shaped to have opposite proximal anddistal ends 25, 27, opposite lateral and medial sides 29, 31, andopposite upper and lower surfaces 33, 35. The resiliently compressiblematerial in this implementation extends between the opposite surfaces33, 35, the opposite ends 25, 27, and the opposite sides 29, 31.

As further detailed in this disclosure, forefoot orthotic device 21 isconstructed, shaped, sized or otherwise configured to address injury,disorder, pain, or other conditions of the forefoot, whether the user isstanding or moving through the gait cycle. The features of device 21reduce, alter, shift or offload force and pressures experienced by theforefoot at different times by the user while standing or during thegait cycle, so as to reduce forces otherwise experienced by anatomicalfeatures of the forefoot which cause pain or inhibit healing or othertreatment of associated foot disorders.

To that end, element 23 is sized and shaped to underlie the forefoot ofa user, with proximal end 25 positioned at the near or proximal end ofthe user's forefoot and distal end 27 positioned forward of proximal end25, toward the forward or distal end of the user's forefoot.

Lateral and medial sides 29, 31 have respective side edges 37, 39. Sideedges 29, 31 are located further from a central longitudinal axis A atdistal end 27 than at proximal end 25. As such, element 23 has definedtherein two, expanded areas 41 located at respective lateral and medialsides 29, 31, but expanded areas 41 are positioned toward distal end 27of element 23, rather than at proximal end 25 thereof. In this way,expanded areas 41 are able to be positioned relative to the user's footso as to underlie the first and fifth metatarsal heads of the user'sfoot. It will be appreciated by those skilled in the art that thelateral spacing of expanded areas 41 may range by certain predeterminedamounts to correspond to the range of sizes of a potential user's foot,whether from child size 1 to adult male size 16. In this implementation,it has been found that predetermined spacing of expanded areas 41 mayrange between 2.5 inches to 3.5 inches, by predetermined amounts tocorrespond to corresponding foot sizes of the intended user.

Expanded areas 41 rapidly transition the first through fifth metatarsalhead areas through the toe off phase of gait where there is highpressure and high forces on metatarsal heads into the propulsion andswing phase of the gait where there are lower pressures with minimalforces on the metatarsals.

Upper surface 33 includes certain features to reduce, alter, transfer,offload or otherwise relieve force experienced by the user's forefootduring standing (stance) or at various points during the user's gaitcycle. For example, in this implementation, upper surface 33 extendsupwardly and inwardly from opposite ends 25, 27 and opposite sides 29,31, and thereby defines on upper surface 33 corresponding, oppositeproximal and distal areas 43, 45 and opposite lateral and medial areas47, 49. Areas 43, 45, 47, 49 have central portions 51 located inwardlyfrom the edges of element 23 and, by virtue of the upward slope of uppersurface 33, the central portions 51 together define a plateau 53 whichis raised relative to a lower plane of reference B defined withreference to lower surface 35 of element 23. In other words, in thisimplementation, there are four areas 41, 43, 45, 47 which generallyslope upwardly from the circumferential edge of element 23, the areasterminating in central portions which together define the plateau 53 ata raised elevation relative to the areas 43, 45, 47 and 49.

In one suitable implementation, lateral and medial areas 47, 49 extendtransversely from respective edges 37, 39 in an arch or arc to form atransverse arch 58 having a radius of curvature selected to providesupport to the metatarsal arch of the user's foot. Arch 58 may have aradius of curvature of 80 mm to 110 mm for a size “large” orthotic foradult male sizes 8.5 to 15, and otherwise ranging −25% to +50% from thatrange for other implementations. In such implementation, the highestpoint of arch 58 is 8.2 mm relative to ground plane B, and may range−25% to +50% therefrom for other sizes or implementations. In otherimplementations, the top of arch 58 is located in plateau 53, andplateau 53 has a height ranging from 5 mm to 13 mm relative to groundplane B.

Lateral and medial areas 47, 49 may be formed of resilientlycompressible material to make areas 47, 49 firmer, more rigid, orotherwise less compressible than adjacent portions of proximal area 43.This physical characteristic may be achieved in a number of ways. Forexample, lateral and medial areas 47, 49 may have a higher durometer,may be formed of compressible material having different compressibilitycharacteristics, or may employ different thicknesses or amounts of suchcompressible material, so that medial and lateral areas 47, 49 are morerigid than adjacent portions of proximal area 43. Since lateral andmedial areas 47, 49 are located closer to the user's metatarsal headsthan proximal area 43, having lateral and medial areas more rigid thanadjacent portions of proximal area 43, may have the effect that, duringuse, portions of the user's foot overlying lateral and medial areas 47,49 are decelerated more than foot portions overlying the adjacentportions of proximal area 43. This may delay arrival of or lessen theforce experienced by the metatarsal region of the forefoot overlyingareas 47, 49 during the impact phase of the gait cycle. In other words,the spacial and angular relationship between proximal area 43 andlateral and medial areas 47, 49 of increased rigidity, slows the speedat which the metatarsal region of the user's forefoot distal to proximalarea 43 receives force from the impact phase of the user's gait.Additionally, the presence of increased resiliency or rigidity inlateral and medial areas 47, 49 slows the rate at which the forefoot isfully loaded during standing or stance phase of the gait. In onesuitable implementation, lateral and medial areas 47, 49 have athickness ranging from 2 mm to 20 mm whereas, distal and proximal areas43, 45 adjacent thereto have thicknesses averaging 1 mm to 10 mm.

The slope and shape of lateral and medial areas 47, 49 direct forceexperienced by overlying forefoot portions laterally or medially,respectively. Additionally, areas 47, 49 accelerate transition from footstrike to propulsion for overlying forefoot portions during the gaitcycle.

The greater rigidity, resilience, or stiffness of lateral and medialareas 47, 49 may be achieved by having resiliently compressible materialof greater thickness at areas 47, 49 than in proximal area 43.Alternately or additionally, element 23 of orthotic device 21 maycomprise resiliently compressible material having different physical orchemical characteristics at different regions of element 23, such thatthe compression load deflection value, rigidity, resilience orcompressibility of the resiliently compressible material in lateral andmedial areas 47, 49 is different from the characteristics of theresiliently compressible material in proximal area 43. Such differencescan be tuned or selected so that, again, lateral and medial areas 47, 49decelerate overlying foot portions more readily than foot portionsoverlying proximal area 43, again with the result of slowing down thearrival of impact force on the metatarsal area forward of proximal area43 and allowing such forces to dwell in proximal area 43 for a greaterperiod of time during the gait cycle, especially the impact phasethereof.

In another variation, distal area 45 may be shaped, configured orotherwise adapted to be less rigid, deflect more readily and/or have acompression load deflection value less than plateau 53 or lateral andmedial areas 47, 49. In this way, under comparable load during use,acceleration of forefoot portions overlying distal area 45 is greaterthan acceleration of forefoot portions overlying lateral and medialareas 47, 49. As such, during stance or gait, weight or impact forcesexperienced in the metatarsal portions of the forefoot proximal orinterior to distal area 45 are offloaded or directed toward distal area45 so that sensitive or pain-prone regions of the forefoot overlyingplateau 53 or lateral and medial areas 47, 49 are minimized, in favor ofoffloading toward less painful, stronger or otherwise more desirableregions toward the front of the user's forefoot or foot overlying distalarea 45.

Distal area 45 may be shaped to slope toward the distal edge and towardlateral and medial edges to direct forces forward, as well as mediallyand laterally away from the midline of the foot.

Lateral and medial areas 47, 49 terminate in respective upper edges 54which are located relatively higher than adjacent portions of proximalarea 43 to define an uphill region 55, and likewise lateral and medialareas 47, 49 have distal edges 56 adjacent distal portion 45 locatedrelatively higher than distal area 45 and thereby defining a downhillregion 57 in distal area 45. As such, during the gait cycle, such asduring impact phase, deceleration of foot portions overlying uphillregion 55 is less than deceleration of foot portions overlying lateraland medial areas 47, 49, plateau 53, and arch 58 to delay impact forceon metatarsal regions forward or distal to proximal area 43. At otherpoints of the gait cycle, such as the end of the impact phase or in thebeginning of the propulsive phase, downhill region 57 acceleratesforefoot portions overlying distal area 45 more than forefoot portionsoverlying arch 58, medial areas 47, 49 or plateau 53, to encourageoffloading or force transfer from anterior or proximal portions of themetatarsals or forefoot forward, such as toward upper metatarsal regionsof the foot forward of the metatarsal heads. Force transfer or offloadas described above likewise occurs when the user is standing orotherwise at stance phase.

In still other implementations of device 21, lower surface 35 has anouter circumference 59 and extends inwardly and upwardly therefromrelative to lower plane of reference B to form a concavity 61 betweenlower surface 35 and plane of reference B. The durometer, compressionload deflection value, or other characteristics of the resilientlycompressible material above concavity 61 may be selected so that forceor weight associated with the user, whether standing or during the gaitcycle, deflects or collapses concavity 61 toward lower plane ofreference B, thereby reducing impact forces otherwise experienced by theforefoot such as on the metatarsal heads.

The characteristics of the resiliently compressible material definingconcavity 61 may, likewise, be selected so that concavity 61 not onlycollapses toward lower plane of reference B, but may be selected so thatthe collapse occurs at points during the gait cycle when the footportions overlying concavity 61 are impacting concavity 61, and theresiliency of concavity 61 is sufficient so that concavity 61 springsback when the force or weight exerted on concavity 61 by overlyingportions of the foot are reduced. Otherwise stated, when foot portionsoverlying concavity 61 are impacting the ground or otherwise exertingsufficient force, concavity 61 will deflect and collapse toward lowerplane of reference B, and when the impact phase of the gait cycle hascompleted and the user is in the toe-off or later phases of the gaitcycle, concavity 61 will, at least partially return to its originalshape in response to reduced force or weight being exerted by theoverlying foot portion.

The particular sizes, shapes and physical characteristics of element 23and its various components and areas may be varied to accomplish theforce or weight transference described herein, the related accelerationor deceleration of overlying portions of the foot relative to eachother, and to promote protection, healing or treatment of forefootconditions of the user. In one suitable implementation, using the 00durometer scale of ASTM Standard 2240, incorporated herein by reference,the resiliently compressible material of element 23 has values rangingfrom 20 to 80. Concavity 61 may be substantially dome shaped, having anaverage radius ranging from 12 mm to 25 mm. Concavity 61 may have amaximum depth ranging from 1 mm to 7 mm, with the point or area ofmaximum depth located below plateau 53. Plateau 53 may have a maximumheight ranging from 5 mm to 13 mm. In one implementation, resilientlycompressible material defining concavity 61 has a thickness of 4 mm,concavity 61 has a radius of 16-22 mm, and a maximum depth of 4 to 6 mm,with the resiliently compressible material having a durometer rangingfrom 40 to 50. Such configuration has been found suitable to causeconcavity 61 to deflect or collapse during the impact phase of a userwithin the weight range of an average adult, and will, likewise, springback during the toe-off or later phases of said user.

The thickness of resiliently compressible material between upper surface33 and lower surface 35 may range from 4 mm to 12 mm. In certainimplementations, thickness of resiliently compressible material betweenconcavity 61 and plateau 53 may range between 4 mm and 6 mm. Theforegoing thickness may be reduced toward the outer circumferentialedges of element 23, especially the outer edges of proximal and distalends 25, 27, to avoid overlying foot portions “feeling” discontinuitiesbetween element 23 and adjacent areas of the shoe, brace, boot, cast orinsole.

In certain implementations, such as those illustrated, upper surface 33of element 23 may be conceptually divided into the four areas discussedabove, namely areas 43, 45, 47 and 49, as well as an additional plateau53 defined at the inner portions of such areas. Plateau 53 may beconsidered a fifth area. In one variation, at least one of the areas,such as proximal area 43, extends upwardly from its proximal end 25toward distal end 27 with an average angle of 9.2°, in one preferredimplementation, but may also range from 8° to 10° in otherimplementations, and terminating in a first, U-shaped boundary 63. TheU-shaped boundary 63 extends transversely from the lateral to the medialsides and has a corresponding first apex 65 located at a height of 8.2mm in one implementation, or may also range from 5 mm to 12 mm relativeto lower plane of reference B. The exact selection of height may vary−25% to +50% to correspond to a respective foot size of the user, suchas sizes ranging from child size 1 to adult male size 16.

Lateral and medial sides 29, 31 and corresponding lateral and medialareas 47, 49 may be shaped and configured such that each of areas 47, 49have a curvilinear, triangular shape with a base 67 located at therespective lateral or medial side 29, 31 and such triangular shapehaving tapering, curvilinear edges extending inwardly to second andthird apices 69, 71. In the illustrated embodiment, first, second andthird apices correspond to upper edges rather than single points, anddefine edges of plateau region 53, and second and third apices have aheight ranging from 5 mm to 12 mm relative to lower plane B. The termapex or apices, as used herein, thus encompasses both high points aswell as high edges.

Furthermore, distal area 45 may extend upwardly from the distal endtoward plateau 53 with an average angle of 17.8° in one preferredimplementation, or ranging from 15° to 20°, in other preferredimplementations, terminating in a second, U-shaped boundary 73. Thesecond, U-shaped boundary has a corresponding fourth apex which mayeither be a point or, as illustrated, an upper edge located at a heightselected as 8.2 mm, or to range from 5 mm to 12 mm relative to lowerplane B in other preferred implementations. The apex of distal area 45may define a forward boundary of plateau 53.

As shown in FIGS. 1 and 3, expanded areas 41 include sloped portions 42of lateral and medial areas 47, 49 and distal area 45, as well asportions of U-shaped boundary 73 and its associated bevel 75. In oneimplementation, U-shaped boundary 73 comprises the apex of slopedportions 42. Given that areas 41 are located to proximate to the likelyposition of metatarsal heads one and five of a user's foot when element23 is in use, sloped portions 42 of expanded areas 41 act to transferimpact or propulsive forces otherwise experienced by metatarsal heads 1and 5 medially in the case of metatarsal head 1 and laterally in thecase of metatarsal head 5, thereby reducing forces likely to beexperienced by metatarsal heads one and five. Sloped portions 42 mayhave multiple radii of curvature corresponding to the shapes of areas45, 47, 49 and bevel 75. In one implementation, in expanded areas 41,areas 47, 49 have radii of curvature ranging from 90 mm to 100 mm. Whenfeatures are described in terms of a radius of curvature, the center ofcurvature is located below upper surface 33, unless apparent otherwiseby reference to the drawings or otherwise specified.

First and second U-shaped boundaries 63, 73 include bevels 75characterized by having greater slope than respective adjacent portionsof upper surface 33. Bevels 75 follow the contours of first and secondboundaries 63, 73 in this variation, and have heights which decreasefrom the lateral, medial edge 37, 39 toward plateau 53, eventuallybecoming zero at plateau 53, so that bevels 75 terminate at plateau 53and first and second boundaries 63, 73 are coplanar with plateau 53 atsuch upper termination point of bevels 75. Bevels 75 have radii ofcurvature (with center point of curvature located above upper surface33) ranging from 2 mm to 5 mm.

Plateau 53 in the illustrated implementation is at the convergence ofareas 43, 45, 47, and 49 of device 21. Its geometric shape and materialsproperties allow for support in the metatarsal arch area, therebyproviding additional offloading of the metatarsal heads and forefoot.

Plateau 53 may be particularly effective during the time in which theheel is off the ground and the foot is transitioning between forefootstrike and propulsion. Plateau 53 provides upward pressure into themetatarsal arch, thereby increasing the reduction of ground forces andperceived pressure on the bottom of the foot.

Though the illustrated implementations of forefoot orthotic device 21are suitable as inserts into footwear, the implementations of thisdisclosure include a forefoot orthotic device which comprises an insole121, shown in FIGS. 7-9. Insole 121 is sized and shaped to underlie thefoot of the user from the heel of the user and extending from the heeldistally by an amount sufficient to underlie at least the metatarsalheads of the user's foot, such amount dictated by predetermined sizes ofthe user's foot ranging from child size 5 to adult male size 15,generally from 8″ (20.3 cm) to 12½′ (31.8 cm). In this implementation,insole 121 includes element 123 with upper surface 133 having expandedareas 141, a proximal area 243, a distal area 145, lateral and medialareas 47, 49 and a plateau 153, the foregoing areas having the features,shapes and configurations similar to those discussed with reference toelement 23 in FIGS. 1-6. Element 123 is secured to insole 121 at alocation adapted to underlie the forefoot of the user when insole 121 isin use. Element 123 may be integrated with the insole, either on thesurface thereof, or within the insole as illustrated in FIG. 9. Insole121 may be configured to allow removal of element 123 therefrom. In oneimplementation, insole for a size “large” as defined previously has atotal length from heel to toe of 30 to 31 cm.

Optionally, insole 121 may be shaped to relieve pressure, providesupport to, or otherwise treat areas of the foot other than theforefoot. For example, insole 121 may include a first portion 127located on the “footprint” of the insole to underlie the user's heel anda second portion 131 distal to the first portion 127 and having an uppersupporting surface 158 located to underlie the user's sagittal arch ormid-foot, distal to the calcaneal cuboid joint. Durometers (scale 00,ASTM 2240) for first portion 127 may be selected to range between 30 and60, and second portion 131 to range between 45 and 70, with a relativedifference preferably of between 10 and 20. Related teachings anddisclosures of co-pending U.S. patent application Ser. No. 13/965,672,published as US 2015/0047221, entitled “Orthotic Insert Device,” by thesame inventor, are hereby incorporated by reference into thisapplication.

The advantageous features of element 23, 123 may be adapted for use inany number of footwear environments, including shoes (includingsneakers), boots, braces and casts, whether for protection, relief,treatment, or prophylactic use, and whether for temporary or continuouseveryday use. Such footwear may incorporate element 23, 123 to treatforefoot conditions while the footwear is being worn. One implementationof the foregoing is shown in FIG. 10, wherein a brace 221 includes aninsole having forefoot element 223 integrated therein.

Referring now to FIGS. 10 and 11, another implementation of thisdisclosure involves combining forefoot element 323 with a suitable sockor sleeve 321, which sleeve 321 is shown appropriately worn about theforefoot of a user in FIG. 10, so that expanded areas 341 are adjacentto or underlie metatarsal heads one and five, thereby obtaining thevarious functional advantages described with reference to the expandedareas of previous embodiments. Element 323 is substantially similar toelements 23, 123, 223 described previously and the combination ofelement 323 with a sock or sleeve 321 as shown permits the varioustreatment, pain relieving, and other therapeutic benefits described. Inthe implementation shown in FIGS. 10 and 11, bevels 375 are generallywider than corresponding bevels 75, have larger radii of curvature,ranging from 5 mm to 15 mm, and have widths ranging from 6 mm to 50 mmfor proximal ones of bevels 375 and from 2 mm to 15 mm for the distalones of bevels 375.

Having described the structures and features of forefoot orthoticdevices 21, 121 and 221, their uses and advantages are apparent. Theforefoot orthotic devices are inserted or fitted to one or both feet ofa user to treat ailments, pain, disorders, amputations, or any number ofother foot conditions affecting the forefoot and which may benefit fromtransfer or movement of forces arising during movement or weight atstance, from the regions of forefoot insult to adjacent regions whereless pain may be experienced. Dimensions may be varied within a rangecorresponding to the respective foot size of the anticipated user.

Expanded areas 41, 141 are located to offload weight or forceexperienced by metatarsal heads one and five away from their normalpoint of contact with the ground, either by urging force forward ofboundary 73 or laterally in the case of metatarsal head five, ormedially in the case of metatarsal head one.

Testing has confirmed the various functions and advantageous featuresdescribed herein in relation to the current art. As previouslyexplained, the features described herein have been shown to deceleratethe speed at which certain regions of the forefoot hit the ground incomparison to other forefoot regions at certain times of the gait cycle,and accelerate such speed at other times of the gait cycle. Pressure isdecreased under the first through fifth metatarsals, especially byvirtue of expanded areas 41 and arch 58 and underlying the metatarsalregion. Standing or at stance, weight otherwise experienced in themetatarsal region is transferred from such region to adjacent regionswhich may be prone to less pain, or such transference may encouragehealing of conditions by reducing weight-bearing activities. Thecombination of features described above decreases impact force in theforefoot region generally, decreases total time on portions of theforefoot, especially the metatarsal heads, and/or acts to decrease loadon the forefoot relative to other portions of the foot.

Testing of certain implementations has shown that the features describedherein decrease the area of the forefoot contacting the ground or shoesole in favor of areas outside the forefoot experiencing such contact,and, thereby, force or pressure on the metatarsal heads iscorrespondingly reduced. These results are applicable whether at stanceor during gait. During gait cycle, not only does the device decrease thepressure under all five metatarsal heads, according to tests results,but the length of time potentially sensitive areas of the forefoot arein contact with the ground is shortened as well, especially under thefirst and fifth metatarsal heads. Testing has shown a 25-80% reductionin pressure or force on metatarsal heads and the forefoot region ingeneral, and a 30-90% decrease in time that the metatarsal heads areexperiencing forces otherwise associated with the gait cycle, suchreductions being compared to the user's gait without the devicedescribed herein.

FIGS. 13A, 13B, and 14A and 14B, are scans showing pressure or force onthe forefoot without and with an orthotic device according to thepresent disclosure. FIGS. 13A, 13B show the forefoot of a left foot whenstanding, that is, statically, 13A corresponding to the forefoot withouta device according to the present disclosure, and FIG. 13B showingpressure or force on the forefoot when a forefoot orthotic deviceaccording to the present disclosure is worn inside a shoe or otherfootwear. Referring to FIG. 13A, the scan of this test shows regions 422corresponding to the great toe, and having green and yellow force bandswhich correspond to greater force or pressure on that region than onregion 422 of FIG. 13B (ranging from blue to black) corresponding to thegreat toe overlying an orthotic device according to the presentdisclosure. Similarly, another region of greater pressure 424 shown ingreen in FIG. 13A corresponds to the first metatarsal head, and can becontrasted with a corresponding region of lower, pressure or force 424′(shown in blue) of FIG. 13B. Further, there is a substantial absence ofpressure or force along portions of the first metatarsal shown at 425′(FIG. 13B) by a white region, in contrast to a blue region of greaterforce (426) shown in FIG. 13A. Still further, referring to FIG. 13A,force or pressure on metatarsal heads 2-5 is shown by color topographyregions 428, including green, yellow and brown regions in FIG. 13Awithout an orthotic device, as opposed to the lesser forces or pressureson metatarsal heads 2-5 shown by the blue areas 428′ in FIG. 13B.

FIGS. 14A and 14B show dynamic test results of the forces or pressureson the forefoot without and with an orthotic device according to thepresent invention shown in terms of force or pressure experienced by theforefoot proximate to the moment of toe-off during the gait cycle. FIG.14A is a left foot of a user without the device disclosed herein, andFIG. 14B is the right foot of the same user with an orthotic device asdisclosed herein. Force or pressure in the regions of metatarsal headsone through five are shown with increased force or pressure without anorthotic device in region 522′ of FIG. 14A with corresponding orangecoloration, whereas metatarsal heads one through five have decreasedforce and pressure exerted thereon when overlying the disclosed orthoticdevice, as shown in FIG. 14B, at regions 522′. Furthermore, the firstmetatarsal, that is, the “great toe,” experiences greater force shown asorange at region 524, without the orthotic device of the presentdisclosure, as opposed to the lower forces or pressure shown as blue orblack in regions 522′ in FIG. 14B corresponding to the great toe. As inthe static test, the first metatarsal has an area of substantiallyreduced force or pressure (shown as white 526′) in contrast to higherpressure in region 526 of the first metatarsal, shown by reference 526in FIG. 14A. In general terms, the test results indicated in FIGS. 13A,13B, and 14A, 14B, demonstrate how orthotic devices 21, 121, 221, 321,decrease contact area, that is, the area experiencing force, in theforefoot, and decrease pressure (that is, force) on metatarsal heads1-5, including substantial decreases in reference to metatarsal oneitself.

While one or more particular implementations have been set out in thisdisclosure, it will be appreciated that various alternatives to thedisclosed structures are likewise contemplated and within the scope ofthis disclosure. For example, although element 23 has been illustratedas substantially comprising resiliently compressible material, othermaterials may be employed, such as non-compressible, flexible material,or non-resilient material. Suitable materials include foam, polymeric,metallic, thermoset or other suitable materials such as foam, plastic,metal, wood, cellulose or other non-foam or non-plastic materials, aloneor in combination. Forefoot orthotic devices herein may employ cloth,antimicrobial, or other materials to enhance ease-of-use, longevity, orversatility. Element 23, 123, 223 may comprise a single molded piece,may consist of multiple substrates, or may be formed of multiplecomponents fused together at opposing edges.

While the illustrated devices are substantially symmetric alonglongitudinal axis A (FIG. 1), other implementations may be asymmetric,may include only one of the expanded areas 41, or may be alteredsymmetrically or asymmetrically to account for left and right feet, orto account for other foot conditions.

Still further variations are contemplated by the disclosure herein,which should be understood to extend to the boundaries of the appendedclaims and equivalents thereto.

1. A forefoot orthotic device for use in connection with a user's foot,the user's foot characterized by a forefoot and metatarsal heads onethrough five, the device comprising: an element sized and shaped tounderlie the forefoot, the element having opposite upper and lowersurfaces, opposite proximal and distal ends, opposite lateral and medialsides, and resiliently compressible material extending between theopposite surfaces, the opposite ends and the opposite sides; wherein theelement has a central longitudinal axis, the lower surface of theelement having at least three points defining a lower plane of referencefor the element when the device is in use; wherein the lateral andmedial sides have respective side edges, the lateral and medial sideedges located further from the central longitudinal axis at the distalend than at the proximal end to define two, expanded areas located atthe lateral and medial sides, respectively, on the distal end of theelement; wherein the expanded areas are laterally spaced from each otherby a predetermined amount between 2.5 inches to 3.5 inches, thepredetermined amount corresponding to the distance between the first andfifth metatarsal heads of the user's foot having a predetermined sizeranging from child size 1 to adult male size 16; and wherein the uppersurface extends upwardly and inwardly from the opposite ends and theopposite sides to define corresponding, opposite proximal and distalareas, and opposite lateral and medial areas, the areas having centralportions defining a plateau raised relative to the lower plane ofreference.
 2. The device of claim 1, wherein the lateral and medialareas extend transversely in an arch from the lateral and medial sideedges, the arch having a radius of curvature ranging from 80 mm to 110mm.
 3. The device of claim 2, wherein the top of the arch is located inthe plateau.
 4. The device of claim 1, wherein the resilientlycompressible material of the element is configured so that the lateraland medial areas are more rigid than portions of the proximal areaadjacent the medial and lateral areas, whereby, during use, decelerationof the foot portions overlying the medial and lateral areas is greaterthan deceleration of foot portions overlying the adjacent portions ofthe proximal area.
 5. The device of claim 4, wherein the resilientlycompressible material under the medial and lateral areas is thicker thanthe resiliently compressible material under the adjacent portions of theproximal area.
 6. The device of claim 5, wherein the thicker resilientlycompressible material of the medial and lateral areas terminates in anupper edge relatively higher than the adjacent portions of the proximalarea to define an uphill region on the upper surface of the element. 7.The device of claim 1, wherein the resiliently compressible material ofthe element is configured so that the medial and lateral areas are morerigid than portions of the distal area adjacent the medial and lateralareas, whereby, during use, acceleration of forefoot portions overlyingthe distal area is greater than acceleration of forefoot portionsoverlying the medial and lateral areas.
 8. The device of claim 1,wherein a lower surface has an outer circumference and extends inwardlyand upwardly therefrom relative to the lower plane of reference todefine a concavity, and wherein the resiliently compressible material isconfigured so that weight associated with the user deflects theconcavity toward the lower plane of reference.
 9. The device of claim 8,wherein the resiliently compressible material is configured to have athickness ranging between 4 mm and 6 mm, a durometer, according to the00 scale, ranging from 20 to 80, and wherein the concavity is defined tohave a radius ranging from 16 mm to 22 mm and a maximum depth rangingfrom 4 mm to 6 mm, whereby the concavity returns from a deflectedposition during impact phase of the gait cycle to an un-deflectedposition after toe-off phase of the gait cycle.
 10. The device of claim1, comprising: an insole sized and shaped to underlie the foot of theuser from the heel of the user, the insole extending from the heeldistally by an amount ranging from 20 cm to 31.8 cm sufficient tounderlie at least the metatarsal heads of the user's foot; and whereinthe element is secured to the insole in a location to underlie theforefoot of the user when the device is in use.
 11. The device of claim10, wherein the element is integrated with the insole.
 12. The device ofclaim 11, wherein the insole includes a first portion underlying theheel and having a first predetermined durometer and a second portionunderlying the sagittal arch of the mid-foot and having a secondpredetermined durometer, and wherein the second predetermined durometeris greater than the first predetermined durometer by amounts rangingbetween 10 and
 20. 13. The device of claim 1, further comprising asleeve sized and shaped to be worn about the forefoot of the user,wherein the element is secured to the sleeve in a location to underliethe forefoot of the user when the device is in use.
 14. The device ofclaim 1, further comprising: footwear selected from the group consistingof a shoe, boot, brace and cast, the footwear having a sole forreceiving the user's foot in an overlying relationship; wherein theelement is operatively associated with the sole of the footwear tounderlie the forefoot of the user when the foot is placed in thefootwear.
 15. The device of claim 14, wherein the footwear includes aninsole, and wherein the element is secured to or integrated with theinsole.
 16. A forefoot orthotic device for use in connection with auser's foot, the device comprising: a resiliently compressible materialextending between upper and lower surfaces, between proximal and distalends, and between lateral and medial sides; wherein the upper surfacehas a circumferential edge and extends upwardly relative to thecircumferential edge to define first, second, third and fourth areas onthe upper surface, and wherein the lower surface has at least threepoints defining a lower plane of reference when the device is in use;wherein the first area extends upwardly from the proximal end toward thedistal end with an average angle ranging from 8° to 10° to terminate ina first boundary, the first area and the first boundary extendingtransversely substantially from the lateral to the medial sides, thefirst boundary having a corresponding first apex located at a heightselected from the range of 6 mm to 10 mm relative to the lower plane ofreference, the selected height corresponding to a respective foot sizeof the user ranging from adult male size 8.5 to adult male size 15;wherein the second area has a curvilinear, triangular shape with a baselocated at the medial side and tapering, curvilinear edges extendinginwardly to a second apex, the second area extending upwardly from themedial side in a convex arc with a radius of curvature selected to rangefrom 80 mm to 110 mm and a height ranging from 6 mm to 12 mm relative tothe lower plane of reference locate the second apex at a the selectedheight corresponding to a respective foot size of the user ranging fromadult male size 8.5 to 15; wherein the third area has a curvilinear,triangular shape with a base located at the lateral side and tapering,curvilinear edges extending inwardly to a third apex, the third areaextending upwardly from the lateral side in a convex arc to locate thethird apex at a selected height ranging from 6 mm to 10 mm relative tothe lower plane of reference, the selected height corresponding to arespective foot size of the user ranging from adult male size 8.5 toadult male size 15; wherein the fourth area extends upwardly from thedistal end toward the proximal end with an average angle ranging from15° to 20° to terminate in a second boundary, the fourth area and thesecond boundary extending transversely substantially from the lateral tothe medial sides, the fourth area having a corresponding fourth apexlocated at a height selected from the range of 6 mm to 10 mm relative tothe lower plane of reference, the selected height corresponding to arespective foot size of the user ranging from adult male size 8.5 toadult male size
 15. 17. The device of claim 16, further comprising aplateau defined on the upper surface and sized and located to includethe apices of each of the four areas.
 18. The device of claim 16,wherein the first and second boundaries comprise respective, U-shapedbevels of greater slope than respective adjacent portions of the uppersurface.
 19. The device of claim 18, wherein the U-shaped bevels haverespective pairs of arms extending from respective bases, and whereinthe bases are located in the plateau, the pair of arms of one of theU-shaped bevels extending away from the pair of arms of the otherU-shaped bevel, one of the pairs of arms extending distally to thedistal end of the upper surface and the other pair of arms extendingproximally toward the proximal end of the upper surface; and wherein thearms of the U-shaped bevels have respective heights, the heightsdecreasing along the arms and becoming zero at the plateau so that thebevels terminate at the plateau.